Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LZA 2019-05-28

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile

Applicant Kossan International Sdn Bhd

K-Number K190606

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MBI 2019-05-28

MectaLock PEEK Suture Anchor

Applicant Medacta International S.A.

K-Number K190474

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NKB 2019-05-28

AccelFix Spinal Fixation System

Applicant L&K BIOMED Co., Ltd.

K-Number K182544

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FPA 2019-05-28

Clearlink System Solution Set

Applicant Baxter Healthcare Corporation

K-Number K180739

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MQV 2019-05-28

IGNITE Bone Void Filler

Applicant Wrightmedicaltechnologyinc

K-Number K190482

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FXX 2019-05-27

Surgical Face Mask

Applicant Wuhan Dymex Healthcare Co., Ltd.

K-Number K182515

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DTQ 2019-05-24

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

Applicant Spectrum Medical , Ltd.

K-Number K190282

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ITX 2019-05-24

Envision ultrasound pad and cover

Applicant Civco Medical Solutions

K-Number K190802

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KGO 2019-05-24

Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

Applicant Molnlycke Health Care Us, LLC

K-Number K190077

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HQF 2019-05-24

LightLas Pattern Scanning System - TruScan Pro

Applicant Light-Med(Usa), Inc.

K-Number K190448

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KOD 2019-05-24

Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter

Applicant Teleflexmedical, Inc.

K-Number K181979

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GEX 2019-05-24

Soliton Acoustic Wave Device

Applicant Soliton, Inc.

K-Number K190542

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